Chief, Veterinary ClinicalServicesAssistant ProfessorYale School of MedicineNew Haven, CT
Attending VeterinarianWestern Connecticut
State UniversityDanbury, CT
Essential Components of an AnimalCare and Use Program
Jodi Scholz, DVM DACLAM
Outline
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Regulations & GuidelinesProgram OversightAnimal Housing & HusbandryVeterinary CareFacilities
Regulations: Where to begin??
Two basic questions:1. Are there USDA-covered species?2. Is the animal research publicly funded?
Regulations: Where to begin??
What is a USDA-covered species?• Warm-blooded animals being used or intendedfor use for research, testing, experimentation, orexhibition purposes
• Excludes: (1) birds, rats of the genus Rattus, andmice of the genus Mus, bred for use in research,(2) horses not used for research, and (3) otherfarm animals used in the production of food orfiber
Animal Welfare Act & Regulations
• AWA is the only Federal law in the US thatregulates the treatment of animals used forteaching, research and exhibition
• The AWA is enforced by USDA, APHIS,Animal Care
• USDA Animal Care is charged withdeveloping and implementing regulations tosupport the AWA
Animal Welfare Act & Regulations• AW Regulations are essentially the manual for
complying with the Act
• Published in Code of Federal Regulations, Title9, Chapter 1, Subchapter A - Animal Welfare(“9CFR”)
– Available online on aphis.usda.gov
• Regs are divided into 4 sections: Definitions,Regulations, Standards, and Rules of PracticeGoverning Proceedings Under the AnimalWelfare Act
• USDA also has 20 published Animal CarePolicies to help interpret some of therequirements of the AWA regs
What does this mean?
• AWA & Regulations must be followed
• Institutions must obtain USDA registration prior tohousing USDA-covered species
• A Veterinary Medical Officer (VMO) employed by USDAAPHIS will make unannounced inspections on at least anannual basis
• Institutions must file an annual report that providesassurance that the AWA is followed and lists the numbersof animals used in research or teaching
Regulations: Where to begin??
Two basic questions:1. Are there USDA-covered species?2. Is the animal research publicly funded?
PHS Policy
• Health Research Extension Act of 1985• Public Health Service Policy on Humane
Care and Use of Laboratory Animals (PHSPolicy)
• Implemented by Office of LaboratoryAnimal Welfare (OLAW)
• Applicable to all activities supported byPHS funds
• Covers any live, vertebrate animal usedfor research
• Institutions with PHS funding must followThe Guide for the Care and Use ofLaboratory Animals
What does this mean?
• Institutions must have an Animal WelfareAssurance with OLAW prior to conducting PHS-supported research
• Assurance must be renewed at least every 4 years• An annual report must be filed annually describingwhether any changes have been made
• A report must be sent to OLAW when there is:– Serious/continued noncompliance with PHS policy– Suspension of a research activity due to noncompliance– Any serious deviation from The Guide
Let’s break it down…
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Program oversightAnimal housingVet careFacilities
Program Oversight: IACUC
• Institutional Animal Care and Use Committee (IACUC)– Responsible for the assessment and oversight of theinstitution’s animal program components and facilities
– Committee must meet as often as necessary to fulfillresponsibilities
– Specific roles:•••••••
Protocol review, including modificationsPost-approval monitoringInspection of facilitiesRegular review of the programOngoing assessment of animal care and useDealing with noncomplianceEstablishing a mechanism for evaluating concerns regarding animalcare and use
Program Oversight: IACUC
IACUC Composition: PHS
• Minimum five members• One DVM with training or
experience in lab animal science• One practicing scientist
experienced in research involvinganimals
• One nonscientific member• One public member that
represents the generalcommunity
• Not more than three membersfrom the same administrativeunit of the institution.
IACUC Composition: AWA
• Minimum three members• One DVM with training or
experience in lab animal science• One unaffiliated member…who
represents the generalcommunity interests in theproper care and treatment ofanimals and is not a laboratoryanimal user.
• Not more than three membersfrom the same administrativeunit of the institution.
Program Oversight: AV & IO• The Attending Veterinarian (AV) is responsible for the
health and well-being of all animals at the institution– Oversees veterinary and other aspects of animal care– Needs to have training or experience with the species being
attended– The institution must grant the AV sufficient authority
• The Institutional Official (IO) bears ultimate responsibilityfor the program– Represents senior administration– Has the authority to allocate resources and ensures alignmentof the program goals with the institution’s mission
– According to the AWA Regulations, is authorized to legallycommit on behalf of the research facility that the AWARegulations will be met
Program Oversight: Training
• All personnel involved with the care and use ofanimals must be adequately educated, trained,and/or qualified– This includes research and animal care personnel– It is the institution’s responsibility to assure thatpersonnel are trained and provide resources fortraining
– Can be formal or informal on-the-job training– IACUC members should also be trained on their rolesand responsibilities
– Training should be documented– Resources are available online
Program Oversight: Occ Health• Each institution must establish and maintain an
occupational health and safety program– Focus on maintaining a safe and healthy workplace environment– Nature depends on the facility, research activities, hazards, and
species– Hazard identification and risk assessment are major roles– Provision of appropriate PPE– Occupational health physicians and nurses, if available
• Health screening– Potential hazards
• Ergonomic issues• Allergens• Noise• Opportunistic infections/zoonotic disease• Chemicals (formalin, anesthetic agents)
Disaster plan
A disaster plan should be in place– Required by both PHS and USDA– USDA mandate: plan in place by July 29th, trainingby September 27th
• Identify potential likely emergencies• Specific tasks that need to be carried out• Chain of command and individuals responsible for eachtask
• Response and recovery handling (materials, resources,training)
– Animal facility disaster plans should be part of theoverall institutional disaster plan
– Law enforcement and emergency personnel shouldbe provided a copy, to incorporate into broaderplanning
Animal Housing & Environment
• Temperature & humidity– Temp ranges by species and humidity ranges listed in the
AWA Regs and The Guide– Temp and humidity should be monitored and recorded
• HVAC– Animal housing rooms: 10-15 air changes per hour– Be aware of positive/negative pressure relative to corridor
• Illumination– Should be diffused appropriately and provide sufficient
lighting for working personnel as well as well-being of thespecies housed
– Rats and mice generally prefer low lighting• Light should be 325 lux or below for albino rodents
Animal Housing & Environment• Noise
– Can be an issue with eithernoise production (dogs, pigs)or sensitivity (rodents)
– Exposure to sounds over 85 dBmay necessitate a hearingprotection program forpersonnel
– Many animals hear soundsoutside of the human hearingrange
• Vibrations– Can disrupt breeding andresearch
– Can come from within oroutside the room/facility
J Am Assoc Lab Anim Sci. 2007 Jan;46(1):20-2
Animal Housing & Environment
• Special considerations for aquatic species– Water quality should be routinely measured– Water should be appropriately conditioned– Chlorine/chloramine must be removed orneutralized
– Room air exchange rates are governed bythermal and moisture loads in the room
– Full-spectrum lighting may be necessary
Animal Housing & Environment
• Cage space requirements– Tables for space requirements by species can befound in the AWA Regs and The Guide
• Enrichment– Providing an environment that supports normalbehavior and reduces abnormal behavior
– Allows animals to cope with the stress of thelaboratory environment
– Social, cognitive, activity, structural– Biological relevance and choice
Animal Husbandry
• Food– Commercially available diets for most species– Appropriate storage for shelf life and vermin control– Open food bags should be stored in vermin-proofsecondary containers
– Most diets expire 6 months after mill date– Less than 70⁰F and below 50% humidity is recommended– Food should be stored off the floor to facilitate sanitation
• Water should be palatable and drinking tubes shouldbe periodically checked for cleanliness andfunctionality
Sanitation
• Cleaning: removes excessive amounts ofexcrement, dirt and debris
• Disinfection: reduces or eliminatesunacceptable concentrations ofmicroorganisms
• Frequency and intensity depends on what isneeded to provide a healthy environment– Depends on species, type of caging, bedding,number of animals, etc
Sanitation
• General guidelines for sanitation:– Enclosures and accessories: at least every two weeks– Solid-bottom cages, bottles, and sipper tubes: at leastonce a week
• Disinfection can utilize chemicals, hot water, orboth– Wash and rinse temps of 140-180 ⁰F is effective– Chemicals may be contraindicated (e.g. aquatics)– Mechanical washers are recommended; hand-washingis acceptable, but attention to detail is required
– Disposable cages are available if a mechanical washer isnot an option
Sanitation
• All components of the animal facility shouldbe regularly cleaned and disinfected
• Effectiveness of sanitation should bemonitored– Temperature strips– Culture– ATP swabs– Certification and maintenance of equipment
Other housing considerations
• Waste management– Hazardous, carcasses
• Pest control program should be in place• Animals need to be cared for daily, includingweekends and holidays
• Animal identification
Veterinary Care
• A veterinary program must be in place• The AV is ultimately responsible for
the care of the animals– Should provide guidance toinvestigators and all personnel toensure appropriate husbandry, medicalcare, handling, sedation, anesthesia,analgesia, surgery, and euthanasia
– According to the AWA Regs, needs tohave graduated from an accredited USvet school (or equivalent)
– Can be full time, part time or on aconsultant basis
• If part time or consultant, visits must beappropriate for programmatic needs
Vet Care: Procurement
• Should be linked to IACUC approval
• Whenever possible, purchase from vendorswho supply purpose-bred animals
• Be aware of population status and whetherpermits/oversight by US Fish and WildlifeService may be appropriate
Vet Care: Transportation
• Can be between or within facilities• Goals
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Provide biosecurityMinimize zoonotic/allergen riskProtect against environmental extremesAvoid overcrowdingProviding for needs and comfort during transportProtection from physical trauma
• Transportation in personal vehicles is discouraged• Special considerations may need to be made foraquatics
Vet Care: Preventative Medicine
• Animal biosecurity– Measures to control infections in laboratory animals– May or may not be a concern depending on animal use
• Quarantine and stabilization– Quarantine or conditioning may or may not be necessarydepending on source, operation setup and experimentalneeds
– Acclimation duration will depend on the mode/duration oftransportation and the intended use of the animals
• Separation by health status• Separation by species
Vet Care: Clinical Medicine
• Animals need to be checked daily• Need a method for communication of healthproblems to the veterinarian
• Plan for emergency care during regular andnon-working hours must be in place
• Documentation process for medical recordsand drug records (controlled substances)– Must comply with state and federal laws
Nuggets to consider…• Make sure that everyone knows how to contact the vet
(directly or through supervisor)– Disseminate or post contact information
• If in doubt, CALL THE VET! We are there to help!• If you have one full/part/consulting vet, have a backup with
contract pre-arranged• It’s a good idea to keep a couple common antibiotics,
analgesics and basic medical supplies on hand• Work out ahead of time as best as possible what the
process is for animals that need treatment (who pays for it?PIs? Facility? Who can administer?)
• If not available in-house, form an arrangement with anearby program for diagnostic pathology services
Vet Care: Surgery
• Pertains to surgery for medical or research needs• Personnel performing surgery or providingperioperative care need to be trained (IACUC isresponsible for ensuring this)
• A dedicated space should be used• Aseptic technique for survival surgeries
– Patient prep– Surgeon prep– Sterile instruments– Proper operative technique
• Intraop monitoring and recovery, includingdocumentation
Vet Care: Pain and Distress• Pain and distress
– All personnel involved in the care for the animals must betrained in assessment of pain and distress for that species
• Anesthesia and analgesia– A veterinarian should be involved in choosing plans– Preemptive analgesia improves stability and recovery– Multimodal approaches to pain are best
• Euthanasia– The act of humanely killing animals by methods that inducerapid unconsciousness and death without pain or distress
– Methods should be consistent with the AVMA Guidelines• New version out in 2013:https://www.avma.org/KB/Policies/Documents/euthanasia.pdf
• Acceptable, acceptable with conditions, unacceptable*other options for destination of the animals after teaching or
experimentation: adoption, transfer, retirement*
Facilities
• A well-designed, properly maintained andmanaged facility is an important aspect ofhumane animal care and use
• Ideal building materials are durable, moisture-proof, vermin-proof, fire-resistant and seamless
• Consider space for:– Animal housing, care, sanitation– Receipt (animals, supplies), quarantine– Separation of species or for health/research reasons– Storage– Animal use/procedures– Personnel: offices, locker rooms, showers, etc
Facilities: General Guidelines
• Corridors– Wide enough for movement of personnel and equipment(rec. 6-8 feet)
– Bumpers and rails, recessed telephones, alarms etc• Doors
– Double doors for some areas (noise, containment)– Viewing windows (ability to cover or red tint)– Should be large enough– Sealed, self-closing, secure
• Windows– The good: enrichment, natural light– The bad: security risk, temp control, interference withphotoperiod
Facilities: General Guidelines
• Floors– Moisture resistant, nonabsorbent, impact resistant– Textured for slip resistance but not too much (difficultto sanitize)
• Drainage– Floor drains may be important– If not needed, should be capped and sealed
• Walls and ceilings– Smooth, moisture resistant, nonabsorbent, resistant toimpact damage
– Suspended ceilings generally undesirable – if present,should be sealed with gaskets and clips and should bewashable
Facilities: General Guidelines
• HVAC– Designed for reliability, ease of maintenance, energyconservation, and meeting the temperature and humiditydemands of the species housed
– Should be able to maintain a temperature +/-2°F andhumidity +/-10%
• Power and lighting– Light and power fixtures should be sealed to preventvermin access
– Time-controlled light cycles with monitoring wheneverpossible
– Emergency power for essential equipment (includingaquatics life support systems)
• Design for noise and vibration control
Facilities: General Guidelines
• Sanitation facility–––––
Separate area for sanitizing cages and equipmentSufficient space for movement and storageSeparation of clean and dirtyVentilation and steam/fume dissipationPersonnel safety
• Hazardous agent containment– Goal: reduce or eliminate hazard exposure to personneland the outside environment
– Follow guidelines described in “Biosafety inMicrobiological and Biomedical Laboratories” (“BMBL”)
Facilities: General Guidelines
• Security and access control– Rationale: containment of allergens, hazardous agents,prevention of pathogen introduction, prevention ofterrorist acts by animal rights extremists
– Animal facility should be located within anotherstructure with its own independent set of securityfeatures
– Control measures: security personnel, physicalbarriers, control devices (security systems, keys,electronic locks)
Essential Resource List
• Animal Welfare Act (AWA) and Regulations (9CFR)• NRC’s Guide for the Care and Use of LaboratoryAnimals, 8th Ed. (“The Guide”)
• OLAW’s Public Health Service Policy on HumaneCare and Use of Laboratory Animals (“PHSPolicy”)
• CDC’s Biosafety in Microbiological and BiomedicalLaboratories (“BMBL”)
• AVMA Guidelines for the Euthanasia of Animals:2013 Edition
Other Great Resources• Occupational Health and Safety in the Care and Use of Research Animals
(NRC)• Guide for the Care and Use of Agricultural Animals in Research and Teaching,
Third Edition, January 2010 (FASS)• ACLAM Position statements (aclam.org), esp:
– Assessment and Management of Pain in Rodents and Rabbits– Report on the ACLAM Task Force on Rodent Euthanasia August 2005
• Institutional Animal Care and Use Committee Guidebook (OLAW)• OLAW.nih.gov• American Association for Laboatory Animal Science (aalas.org)• Association for Assessment and Accreditation of Laboratory Animal Care
(aaalac.org)• Animal Welfare Information Center (USDA) (awic.nal.usda.gov)• Animal Welfare Institute (awionline.org)• The Enrichment Record (enrichmentrecord.com)• Collaborative Institutional Training Initiative (citiprogram.org)• COMPMED listserv (http://www.aalas.org/online_resources/listserves.aspx)
